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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03136900
Other study ID # P2017/PICU/DIETCHIRCARD
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 3, 2017
Est. completion date April 17, 2020

Study information

Verified date June 2020
Source Queen Fabiola Children's University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.

After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.

The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.


Recruitment information / eligibility

Status Terminated
Enrollment 41
Est. completion date April 17, 2020
Est. primary completion date April 17, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria:

- Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation

- Expected stay of 5 days in PICU after surgery

- Expected need of invasive ventilation for 48h after surgery

- Expected need for enteral feeding during 5 days.

- Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study

Exclusion Criteria:

- Medical indications for specific diet

- ECMO

- Dialysis

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nutrilon without lactose® fortified by concentration
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
enteral diet with cow milk protein-based infant formula without lactose 14%

Locations

Country Name City State
Belgium Hôpital Universitaire Des Enfants Reine Fabiola Brussels

Sponsors (1)

Lead Sponsor Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary positive nitrogen balance Day 5 post operative
Secondary duration of enteral feeding duration in hour up to 120 days post operative
Secondary duration of invasive or non-invasive ventilatory support duration in hour up to 120 days post operative
Secondary length of hospital stay in intensive care unit duration in hour up to 120 days post operative
Secondary length of hospital stay in hospital duration in hour up to 120 days post operative
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